Quality Assurance Manager


Full Time

Framingham, MA

Reporting to the SVP, Operations & General Counsel, the QA Manager is responsible for the duties outlined below.

Responsibilities

  • Manage the electronic Quality Management System (eQMS) (MasterControl)
  • Serve as resident Quality expert in support of QMS activities (GLP, GCP, and CLIA)
  • Serve as System administrator for eQMS system
  • Configure and implement Process and Auditing modules to expand usage of system
  • Provide day-to-day management of document control processes and workflows within the EDMS
  • Manage any regulatory or governing body certifications (CLIA)
  • Manage change control, CAPA, deviation, and investigation programs
  • Review and approve executed documents including validation documents, reports that could be filed
    in support of regulatory submissions, and operating procedures.
  • Oversee the internal and external audit program, which includes, focus on GxP, GLP, GCP, CLIA
    compliance, regulatory agency inspection readiness, and for-cause inspections
  • Provide support to Clinical Team and Laboratory to ensure compliance with GCP’s, GLPs and
    applicable regulatory requirements
  • Facilitate vendor management
  • Responsible for facilitation and maintenance training records
  • Responsible for records management and facilitation of off-site records storage.
  • Serve as Safety Officer, responsible for implementation, management, and enforcement of environmental health and safety programs at BERG
  • Serve as Privacy Officer, responsible for the organization’s Privacy and Security Program including but not limited to daily operations of the program, development,
    implementation, and maintenance of policies and procedures, monitoring program compliance, investigation and tracking of incidents and breaches and insuring
    patients’ rights in compliance with federal and state laws. Complete appropriate certification.
  • Identify, develop, and communicate a metrics (KPI) system to drive awareness and improvement measurement

Qualifications

  • Requires a Bachelor’s (Master’s degree preferred) in a related scientific discipline with 8-10 years’ experience in QA in a GxP regulated environment
  • Must have successful implementation experience and management of a QMS System
  • Must demonstrate attention to detail and excellent record keeping skills
  • Must be proficient in MS Office Suite (e.g. Word, Excel, PPT) required for review and preparation of documents and reports for inspections
  • Proven ability to find creative, practical solutions to complex problems
  • Excellent communication and interpersonal skills
  • Superior and proven organizational skills
  • Ability to multitask and work in a team-oriented fast-paced environment